PEEK PREVAIL™ Cervical Interbody Device

GUDID 00613994646002

SPACER 9010000038 PRV PK 16X12X8

MEDTRONIC SOFAMOR DANEK, INC.

Polymeric spinal fusion cage, sterile

• Primary Device ID: 00613994646002
• NIH Device Record Key: d76c9d96-bfae-4706-bbb8-15b4a448ffb5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PEEK PREVAIL™ Cervical Interbody Device
• Version Model Number: 9010000038
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994646002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K094042

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-01

On-Brand Devices [PEEK PREVAIL™ Cervical Interbody Device]

• 00613994853264: HANDLE 1204477 SCREW GUIDE
• 00613994753922: SCREW GUIDE 1225555
• 00613994646019: SPACER 9010000039 PRV PK 16X12X9
• 00613994646002: SPACER 9010000038 PRV PK 16X12X8
• 00613994645999: SPACER 9010000037 PRV PK 16X12X7
• 00613994645982: SPACER 9010000036 PRV PK 16X12X6
• 00613994645975: SPACER 9010000035 PRV PK 16X12X5
• 00613994645777: TRASP 9010000049 CERVICAL 9X16X12
• 00613994645760: TRASP 9010000048 CERVICAL 8X16X12
• 00613994645753: TRASP 9010000047 CERVICAL 7X16X12
• 00613994645746: TRASP 9010000046 CERVICAL 6X16X12
• 00613994645739: TRASP 9010000045 CERVICAL 5X16X12
• 00613994502124: IMPLANT 4210964 STANDALONE 16 X 14 X 9MM
• 00613994502117: IMPLANT 4210864 STANDALONE 16 X 14 X 8MM
• 00613994502100: IMPLANT 4210764 STANDALONE 16 X 14 X 7MM
• 00613994502094: IMPLANT 4210664 STANDALONE 16 X 14 X 6MM
• 00613994502087: IMPLANT 4210564 STANDALONE 16 X 14 X 5MM